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Research Letter
September 2018

Assessment of Pragmatism in Recently Published Randomized Clinical Trials

Author Affiliations
  • 1Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, California
  • 2Epidemiology Unit, Health Research Institute–Fundación Jiménez Díaz University Hospital, Universidad Autónoma de Madrid, Madrid, Spain
  • 3Departments of Medicine, Health Research and Policy, Biomedical Data Science, Statistics, Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, California
JAMA Intern Med. 2018;178(9):1278-1280. doi:10.1001/jamainternmed.2018.3321

Pragmatic randomized clinical trials (pRCTs) are considered a highly valuable design, providing evidence for clinical decisions in real-world settings.1 The conduct and setting of pRCTs mimic the usual practice of care while trying to maintain the internal validity of randomization,2 and they are becoming increasingly common.3 Their perceived and documented strengths and weaknesses need to be empirically studied beyond the theoretical expectations. In this study, we assessed the main characteristics among numerous recently published RCTs tagged as pragmatic, how the authors supported their claims for pragmatism, and whether major limitations stemming from the pragmatic design were noted in the articles.

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